Diplomat becomes distributor of recently approved cancer drug
FLINT, Mich. — Diplomat has become a distributor of a new cancer drug made by Genentech, Diplomat said Thursday.
The specialty pharmacy company said it had received a distribution contract for Gazyva (obinutuzumab) for chronic lymphocytic leukemia, which received Food and Drug Administration approval on Nov. 1. CLL is a slowly advancing blood and bone marrow disease that, according to the National Cancer Institute, part of the National Institutes of Health, will be diagnosed in 15,680 Americans this year and cause 4,580 deaths.
"We are pleased to partner with Genentech as a specialty pharmacy provider of Gazyva," Diplomat president Gary Kadlec said. "With our extensive clinical and industry experience with new and emerging drug therapies, we are committed to providing Gazyva according to Diplomat’s high standards and industry-leading protocols, enabling patients to obtain the best outcomes possible."
The drug is administered intravenously in conjunction with chlorambucil, a chemotherapy drug also used to treat CLL. The drug’s labeling includes a boxed warning, the highest-level warning a drug can carry, due to the risk of viral reactivation in patients with hepatitis B and the risk of progressive multifocal leukoencephalopathy, or PML, a rare disorder that damages the material covering and protecting nerves in the white matter of the brain.
CORRECTION: A previous version of this story reported that Diplomat had joined a limited-distribution network for Gazyva, based on an erroneous statement in the specialty pharmacy’s press release. Gazyva is an open-distribution drug for which Diplomat has been named a distributor. This version of the story corrects the error.
Actelion launches Valchlor
SOUTH SAN FRANCISCO, Calif. – Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.
Actelion announced the launch of Valchlor (mechlorethamine), which the Food and Drug Administration approved in August for treating stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patient who have received skin-directed therapy before. Actelion acquired rights to the drug when it merged with Ceptaris Therapeutics. Accredo Specialty Pharmacy distributes the drug in the United States.
"The availability of Valchlor is exciting news for patients and the treatment community," Stanford University School of Medicine professor and director of the school’s Multidisciplinary Cutaneous Lymphoma Clinic Youn Kim said in a statement on behalf of Actelion. "Physicians now have the option to treat appropriate MF-CTCL patients with the first formulation of topical mechlorethamine that is FDA-approved based on rigorous clinical evidence to support its use."
Perrigo completes $8.6 billion acquisition of Elan Corp.
DUBLIN — Perrigo has finalized its acquisition of Elan Corp., Perrigo said Wednesday.
The Michigan-based maker of branded and generic prescription and OTC drugs announced last week that the Irish High Court had approved its $8.6 billion deal to buy Ireland-based Elan, the last regulatory hurdle it had to clear before finalizing the deal, which it announced in July.
"The combined company establishes a diversified platform that will position Perrigo well for further expansion," Perrigo chairman and CEO Joseph Papa said. "When combined with the royalty stream from Tysabri, a blockbuster product that generated revenues of $1.6 billion last year, this platform will create an industry-leading global healthcare company with the balance sheet liquidity and operational structure to accelerate our growth."